Systems and methods for delivering agents into targeted tissue of a living being

Abstract

Delivery systems for accessing the targeted tissue within the living being and introduction of at least one agent at select locations into the tissues of the heart such as the myocardium and other select tissues. Where appropriate, portions of the system are steerable to properly orient the device. When tissue penetration is utilized, the device may include a feature to control the depth of penetration. removal. The system may utilize some form of mechanical action or application of energy (e.g. electrical, sonic, thermal, optical, pressurized fluid, radio frequency (RF), nuclear) in the process. The agent delivered to the tissue may include one or more of pharmaceuticals, biologically active agents, radiopaque materials, etc.

1. A tissue treatment system to beneficially treat target tissue within a living being, wherein said target tissue is distant from an entry situs in non-target tissue, said system comprising a delivery system and a first flowable agent, wherein at least a distal end of said delivery system is arranged to be introduced into an interior lumen of the body of a living being and to supply kinetic energy and pressure to said first flowable agent to introduce said first flowable agent at an entry situs comprising a wall defining said lumen, wherein at least a portion of said first flowable agent is delivered non-systemically, with such energy and pressure additionally causing said first flowable agent to penetrate said non-target tissue without any mechanical means carrying said first flowable agent through said non-target tissue, wherein further said first flowable agent comprises at least one of saline, pharmaceuticals, growth factors, biomaterials, genetic based material or cellular based material, and wherein said pressure comprises a high pressure of at least several thousand psi, whereupon said first flowable agent enters said target tissue located beyond said wall of said lumen. 
   
   
     2. The system of  claim 1  wherein said first flowable agent additionally comprises small particles. 
   
   
     3. The system of  claim 2  wherein said small particles comprise microspheres. 
   
   
     4. The system of  claim 3  wherein said microspheres comprise at least one of resorbable materials, non-resorbable materials or partially resorbable materials. 
   
   
     5. The system of  claim 4  wherein said microspheres are arranged for time-phased delivery of said beneficial treatment. 
   
   
     6. The system of  claim 2  wherein said first flowable agent additionally comprises a carrier. 
   
   
     7. The system of  claim 6  wherein said carrier comprises a fluid or a gel. 
   
   
     8. A tissue treatment system to beneficially treat target tissue within a living being, wherein said target tissue is distant from an entry situs in non-target tissue, said system comprising a delivery system and a first flowable agent, wherein at least a distal end of said delivery system is arranged to be introduced into an interior lumen of the body of a living being and to supply kinetic energy and pressure to said first flowable agent to introduce said first flowable agent at an entry situs comprising a wall defining said lumen, wherein at least a portion of said first flowable agent is delivered non-systemically, with such energy and pressure additionally causing said first flowable agent to penetrate said non-target tissue without any mechanical means carrying said first flowable agent through said non-target tissue, wherein said pressure comprises a high pressure of at least several thousand psi, whereupon said first flowable agent enters said target tissue located beyond said wall of said lumen, wherein said kinetic energy enables said first flowable agent to create a channel at said entry situs to facilitate said penetration, and wherein said system additionally comprises a second flowable agent. 
   
   
     9. The system of  claim 8  wherein said second flowable agent is delivered systemically. 
   
   
     10. The system of  claim 8  wherein said second flowable agent comprises at least one of saline, pharmaceuticals, growth factors, biomaterials, genetic based material, cellular based material, or other beneficial agent. 
   
   
     11. The system of  claim 10  wherein said second flowable agent additionally comprises small particles. 
   
   
     12. The system of  claim 11  wherein said small particles comprise microspheres. 
   
   
     13. The system of  claim 12  wherein said microspheres comprise at least one of resorbable materials, non-resorbable materials or partially resorbable materials. 
   
   
     14. The system of  claim 11  wherein said second flowable agent additionally comprises a carrier. 
   
   
     15. A tissue treatment system to beneficially treat target tissue within a living being, wherein said target tissue is distant from an entry situs in non-target tissue, said system comprising a delivery system and a first flowable agent, wherein at least a distal end of said delivery system is arranged to be introduced into an interior lumen within the body of a living being and to supply kinetic energy and pressure to said first flowable agent to introduce said first flowable agent at an entry situs comprising a wall defining said lumen, wherein at least a portion of said first flowable agent is delivered non-systemically, with such energy and pressure additionally causing said first flowable agent to penetrate said non-target tissue without any mechanical means carrying said first flowable agent through said non-target tissue, wherein said pressure comprises a high pressure of at least several thousand psi, whereupon said first flowable agent enters said target tissue located beyond said wall of said lumen, and wherein said delivery system is arranged to be operated at an approximate center of a lumen through which said system is introduced. 
   
   
     16. A system for delivering a flowable agent to target tissue, comprising:
 a reservoir containing a flowable agent therein, the reservoir arranged to generate a high pressure sufficient to cause said flowable agent to enter target tissue; and 
 
     a delivery instrument including an elongate shaft having a proximal end, a distal end and a flow path therethrough, the proximal end of the shaft connected to the reservoir, the flow path in fluid communication with the flowable agent contained in the reservoir, the distal end of the shaft including an outlet port in fluid communication with the flow path such that fluid from the reservoir may be delivered to the target tissue via the flow path and the outlet port at a sufficiently high pressure and exit velocity to at least partially penetrate the target tissue, without any mechanical means carrying said fluid, wherein said sufficiently high pressure comprises a pressure of at least several thousand psi, and further wherein at least said distal end of said delivery instrument is arranged to be inserted into a living being through an interior lumen of said living being; further wherein said fluid accesses said target tissue by traversing tissue making up a wall defining said lumen, and wherein said delivery instrument is arranged to be operated at an approximate center of a lumen through which said delivery instrument is introduced. 
   
   
     17. A system for delivering a flowable agent to target tissue, comprising:
 a reservoir containing a flowable agent therein, the reservoir arranged to generate a high pressure sufficient to cause said flowable agent to enter target tissue; and 
 a delivery instrument including an elongate shaft having a proximal end, a distal end and a flow path therethrough, the proximal end of the shaft connected to the reservoir, the flow path in fluid communication with the flowable agent contained in the reservoir, the distal end of the shaft including an outlet port in fluid communication with the flow path such that fluid from the reservoir may be delivered to the target tissue via the flow path and the outlet port at a sufficiently high pressure and exit velocity to at least partially penetrate the target tissue, without any mechanical means carrying said fluid, wherein said sufficiently high pressure comprises a pressure of at least several thousand psi, and wherein at least said distal end of said delivery instrument is arranged to be inserted into a living being through an interior lumen of said living being, further wherein said fluid accesses said target tissue by traversing tissue making up a wall defining said lumen, and wherein said flowable agent further comprises a carrier comprising at least one of a liquid and a gel. 
 
   
   
     18. A tissue treatment system to beneficially treat target tissue within a living being, wherein said target tissue is distant front an entry situs in non-target tissue, said system comprising a delivery system and a first flowable agent, wherein at least a distal end of said delivery system is arranged to be introduced into an interior lumen of the body of a living being and to supply kinetic energy and pressure to said first flowable agent to introduce said first flowable agent at an entry situs comprising a wall defining said lumen, wherein at least a portion of said first flowable agent is delivered non-systemically, with such energy and pressure additionally causing said first flowable agent to penetrate said non-target tissue without any mechanical means carrying said first flowable agent through said non-target tissue, wherein said pressure comprises a high pressure, whereupon said first flowable agent enters said target tissue located beyond said wall of said lumen, and wherein said high pressure comprises a pressure of at least several thousand psi. 
   
   
     19. The system of  claim 17 , wherein the flowable agent is distributed into said target tissue. 
   
   
     20. The tissue treatment system of  claim 18 , wherein said flowable agent is dispersed into said target tissue.